MODIFICATION TO: SAVI APPLICATOR KIT

K080565 · Cianna Medical, Inc. · JAQ · Apr 4, 2008 · Radiology

Device Facts

• Record ID: K080565
• Device Name: MODIFICATION TO: SAVI APPLICATOR KIT
• Applicant: Cianna Medical, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Apr 4, 2008
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SAVI Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Device Story

SAVI Applicator is an expandable, single-use, sterile cylindrical device with radially positioned catheters; inserted into target volume during brachytherapy. Functions as an accessory to remote afterloading equipment; provides pathways for delivery of prescribed radiation dose to treatment area. Used by clinicians in clinical settings. Output is physical pathway for radiation source; enables targeted dose delivery. FDA requires specific warning that safety/effectiveness for breast brachytherapy as replacement for whole breast irradiation is not established.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Expandable cylindrical device with multiple radially positioned catheters. Single-use, sterile. Functions as an accessory to remote afterloading brachytherapy equipment. No software or electronic components.

Indications for Use

Indicated for use as an accessory to remote afterloading equipment for brachytherapy procedures to provide pathways for radiation dose delivery to a treatment area. Prescription use only.

Regulatory Classification

Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Predicate Devices

• Biolucent Applicator (K062830, K061241, K070659)

Submission Summary (Full Text)

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K080565

Cianna Medical, Inc. 510(k) Submission- Special SAVI Applicator Kit

| 5. 510(k) Summary of Safety and Effectiveness | |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | APR - 4 2008 |
| Device Name: | SAVI Applicator |
| Device Model Number: | RTK-006<br>RTK-008<br>RTK-010 |
| Classification Name: | Remote Controlled Radionuclide Applicator System<br>(JAQ),<br>21 CFR, 892.5700 |
| Device Classification: | Class II |
| Predicate devices: | Biolucent Applicator (K062830, K061241,<br>K070659) |
| Manufacturer: | Cianna Medical<br>6 Journey, Suite 125<br>Aliso Viejo, CA 92656 |
| Owner/Operator Number: | 9044581 |
| Establishment Registration<br>Number: | 2032338 |
| Official Contact: | Gary Mocnik<br>Cianna Medical.<br>6 Journey, Suite 125<br>Aliso Viejo, CA 92656<br>Phone: [phone] x134<br>[e-mail] |

#### Intended Use:

The SAVI Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

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### Device Description:

The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.

# Technological Characteristics Summary

The SAVI Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.

## Performance Data Summary

Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device.

### Conclusion:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the SAVI Applicator is determined to be substantially equivalent to existing legally marketed devices

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APR - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary Mocnik Vice President, Regulatory Affairs and Quality Systems Cianna Medical, Inc. 6 Journey, Suite 125 ALISO VIEJO CA 92656

Re: K080565 Trade/Device Name: SAVI Applicator Kit Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: February 29, 2008 Received: March 5, 2008

Dear Mr. Mocnik:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of the SAVI Applicator Kit for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The Warning must be presented within a black box, and the font should be bold and the same size as any surrounding text. The Warning should be the first item in your list of warnings. The safety and effectiveness of this device for use as replacement for whole breast irradiation in the treatment of breast cancer have not been established.

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Page 2 - Mr. Gary Mocnik

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International, and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 0805b5

Device Name: SAVI Applicator Kit

Indications for Use:

The SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

OR

Over-The-Counter Use

Prescription Use X (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number.